MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 29GA 1/2IN 10BAG 500 PL/WG; PISTON SYRINGE

Model Number 928851

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Hypoglycemia (1912)

Event Date 01/12/2021

Event Type  Injury  

Manufacturer Narrative

"a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).".

Event Description

It was reported that a syringe 0.5ml 29ga 1/2in 10bag 500 pl/wg had missing label information during use leading to hypoglycemia.The following was reported by the initial reporter: "it was reported that the consumer had a low blood glucose event and the lot# was missing from the outside of the box.Verbatim: from phone call on 2021-01-13 15:01:20: update verbatim consumer stated used u500 insulin with this u100 syringe, as per doctor and got a low blood glucose event.Consumer reported using this u100 syringe with her u500 lilly insulin.Morning glucose readings 51.Informed caller to speak with her doctor or pharmacist.She stated they don't know what is the issue but i feel i'm missed dosed myself because of this.Informed caller they are for u100 insulin only not u500 and to see an endocrinologist.Lot #: 9231293a from the bag- missing from the box catalog#: 928851, date of event: (b)(6) 2021, samples status - no-- she declined the mailing kit and refund -then ended the call consumer reported the lot number field on the box was blank.Lot #: unknown from box obtain lot # 9231293a, from the bag.Catalog#: 928851 date of event: (b)(6) 2021 samples status no consumer ended call.".

Manufacturer Narrative

H6: investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 9252463.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.

Event Description

It was reported that a syringe 0.5ml 29ga 1/2in 10bag 500 pl/wg had missing label information during use leading to hypoglycemia.The following was reported by the initial reporter: "it was reported that the consumer had a low blood glucose event and the lot# was missing from the outside of the box.Verbatim: from phone call on 2021-01-13 15:01:20: update verbatim consumer stated used u500 insulin with this u100 syringe, as per doctor and got a low blood glucose event.Consumer reported using this u100 syringe with her u500 lilly insulin.Morning glucose readings 51.Informed caller to speak with her doctor or pharmacist.She stated they don't know what is the issue but i feel i'm missed dosed myself because of this.Informed caller they are for u100 insulin only not u500 and to see an endocrinologist.Lot #: 9231293a from the bag- missing from the box catalog#: 928851date of event: (b)(6) 2021 samples status - no-- she declined the mailing kit and refund -then ended the callconsumer reported the lot number field on the box was blank.Lot #: unknown from box obtain lot # 9231293a from the bag.Catalog#: 928851.Date of event: (b)(6) 2021 samples status no consumer ended call.".

• Brand Name: SYRINGE 0.5ML 29GA 1/2IN 10BAG 500 PL/WG
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11263988
• MDR Text Key: 229827771
• Report Number: 1920898-2021-00140
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00311917014890
• UDI-Public: 00311917014890
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 928851
• Device Catalogue Number: 928851
• Device Lot Number: 9231293
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other